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FDA 510(k) Application Details - K221520
Device Classification Name
Dressing, Wound, Collagen
More FDA Info for this Device
510(K) Number
K221520
Device Name
Dressing, Wound, Collagen
Applicant
Reprise Biomedical, Inc.
17400 Medina Road Suite 100
Plymouth, MN 55447 US
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Contact
Herzog Kathy
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
KGN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/25/2022
Decision Date
08/18/2022
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
-
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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